Text Size

Integrative Therapy in Alcoholism

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Addiction Research Network
Merck Santé
University Hospital, Bonn
Universität Duisburg-Essen
University of Homburg
Psychosomatic Clinic of Bergisch Gladbach
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00159107
First received: September 7, 2005
Last updated: January 29, 2008
Last verified: October 2007
History of Changes

September 7, 2005
January 29, 2008
May 2003
Not Provided
Abstinence [ Time Frame: 3,6,12 months ]
  • Abstinence
  • Alcohol consumption
Complete list of historical versions of study NCT00159107 on ClinicalTrials.gov Archive Site
  • Social functioning [ Time Frame: 12 months ]
  • Cognitive functioning [ Time Frame: 12 months ]
  • Social functioning
  • Cognitive functioning
Not Provided
Not Provided
 
Integrative Therapy in Alcoholism
Acamprosate and Integrative Behavior Therapy in the Outpatient Treatment of Alcohol Dependents

The main aim of this project consists in the investigation of the interaction of behavior therapy and Acamprosate in the outpatient treatment of alcoholic patients in a randomized, prospective and (regarding study medication Acamprosate vs. Placebo) double blind design. A total of 371 patients has been randomly assigned immediately after detoxification to one of three different outpatient treat-ment conditions.

The objective of this multi-center study is to optimize the long-term treatment of patients with alcohol dependence. This investigation should contribute to the issue of effective relapse prevention. Each treatment condition is lasting 6 months: a) Behavior Group Therapy + Acamprosate, b) Behavior Group Therapy + Placebo and c) support and counseling + Acamprosate. Follow-up examinations carried out 3 and 6 months after the end of treatment.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcoholism
  • Drug: Acamprosate
    Acamprosate
  • Behavioral: Integrative behavior therapy
    Integrative behavior therapy
  • Drug: Placebo
    Placebo
  • Experimental: 2
    Placebo +Integrative behavior therapy
    Interventions:
    • Behavioral: Integrative behavior therapy
    • Drug: Placebo
  • Experimental: 3
    Acamprosate + treatment as usual
    Intervention: Drug: Acamprosate
  • Experimental: 1
    Acamprosate + Integrative behavior therapy
    Interventions:
    • Drug: Acamprosate
    • Behavioral: Integrative behavior therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
371
December 2006
Not Provided

Inclusion Criteria:

  • DSMIV criteria of alcoholism
  • Age between 25 and 60
  • Informed consent

Exclusion Criteria:

  • Residence outside of the catchment area
  • Legal reasons
  • Insufficient knowledge of the German language
  • Substance abuse or addiction other than alcohol or nicotine
  • Pregnancy
  • Serious physical illness
  • Organic brain disease
  • Contraindication to Acamprosate treatment
Both
25 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00159107
01EB0133
Yes
Not Provided
Heinrich-Heine University, Duesseldorf
  • German Federal Ministry of Education and Research
  • German Addiction Research Network
  • Merck Santé
  • University Hospital, Bonn
  • Universität Duisburg-Essen
  • University of Homburg
  • Psychosomatic Clinic of Bergisch Gladbach
Study Chair: Wolfgang Gaebel, Professor Department of Psychiatry and Psychotherapy, University of Düsseldorf
Heinrich-Heine University, Duesseldorf
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP